Wearable auricular neurostimulator and methods of use

Abstract

In an illustrative embodiment, a wearable auricular stimulator includes a flexible body adapted to be worn at least partially around an auricle of a wearer, including an exterior for positioning in contact with a wearer's skin, and an interior for supporting a three-dimensional (3D) circuitry layout, including traces deposited on surfaces of the interior of the flexible body, electrodes for delivering electrical stimulation therapy to the wearer via a skin-facing side of the flexible body, and electronic component(s) electrically connected with the electrodes and the traces, the electronic components including a processing circuitry element for delivering electrical stimulation treatment(s) via the electrodes.

What is claimed is: 
     
       1. A system for increasing coagulation speed and/or reducing bleeding in an individual using a wearable stimulation device, the system comprising:
 a wearable auricular stimulator, comprising
 a flexible body adapted to be worn at least partially around an auricle of a wearer, the flexible body comprising
 an exterior comprising a skin-facing side for positioning in contact with skin of the wearer, and 
 an interior for supporting a three-dimensional circuitry layout, and 
 
 the three-dimensional circuitry layout, comprising
 a plurality of electrodes configured to deliver electrical stimulation therapy to the wearer via the skin-facing side of the flexible body, wherein the plurality of electrodes comprise at least one of
 a first electrode of the plurality of electrodes configured for positioning over or adjacent to a branch of an auriculotemporal nerve (ATN), or 
 a second electrode of the plurality of electrodes configured for positioning over or in proximity to an auricular branch of a vagus nerve (ABVN), and 
 
 one or more electronic circuitry components, each electronic circuitry component of the one or more electronic circuitry components being electrically coupled with i) a portion of the plurality of electrodes and/or ii) one or more flexible conductive traces of a plurality of flexible conductive traces deposited on surfaces of the interior of the flexible body, the one or more electronic circuitry components comprising a neurostimulation control component including processing circuitry configured to deliver at least one electrical stimulation treatment via the plurality of electrodes; and 
 
 
 a controller configured to instruct the processing circuitry of the one or more electronic circuitry components to deliver, via the plurality of electrodes, the at least one electrical stimulation treatment for increasing coagulation speed and/or reducing bleeding in the wearer, wherein the at least one electrical stimulation treatment comprises
 stimulating, via the first electrode, the ATN, and/or 
 stimulating, via the second electrode, the ABVN; 
 
 wherein the flexible body of the wearable auricular stimulator comprises a plurality of openings and/or a plurality of thinned regions of material of the flexible body for enabling electrical communication between each electrode of the plurality of electrodes and the skin of the wearer. 
 
     
     
       2. The system of  claim 1 , wherein:
 the interior of the flexible body comprises at least one protrusion; and 
 each respective electronic circuitry component of at least one electronic circuitry component of the one or more electronic circuitry components of the three-dimensional circuitry layout is disposed on or above a respective one or more protrusions of the at least one protrusion. 
 
     
     
       3. The system of  claim 1 , wherein the at least one electrical stimulation treatment is configured to improve coagulation potential and/or reduce bleeding potential in advance of bleeding in the wearer. 
     
     
       4. The system of  claim 3 , wherein the at least one electrical stimulation treatment is configured for delivery to the wearer prior to a surgical procedure. 
     
     
       5. The system of  claim 1 , wherein the at least one electrical stimulation treatment is configured for delivery to the wearer having a coagulation disorder. 
     
     
       6. The system of  claim 5 , wherein the coagulation disorder is one of hemophilia, hemophilia A, hemophilia B, hemophilia C, Von Willebrand disease (VWD), Factor I deficiency, Factor II deficiency, Factor V deficiency, Factor VII deficiency, Factor X deficiency, Factor XII deficiency, or Factor XIII deficiency. 
     
     
       7. The system of  claim 1 , wherein the at least one electrical stimulation treatment is configured to treat menorrhagia and/or heavy menstrual bleeding. 
     
     
       8. The system of  claim 1 , wherein the at least one electrical stimulation treatment is configured to treat internal bleeding. 
     
     
       9. The system of  claim 1 , wherein the wearable auricular stimulator comprises the controller. 
     
     
       10. The system of  claim 1 , wherein the neurostimulation control component comprises the controller. 
     
     
       11. The system of  claim 1 , wherein the one or more electronic circuitry components further comprises one or more of an illumination circuitry component, a mechanical input control component, a communications component, or a memory component. 
     
     
       12. The system of  claim 1 , wherein:
 the flexible body comprises one or more wells formed in the interior; and 
 a portion of the plurality of flexible conductive traces extend into each well of at least a portion of the one or more wells. 
 
     
     
       13. The system of  claim 1 , wherein at least one electronic circuitry component of the one or more electronic circuitry components is integrated into at least one circuit board component, wherein
 electrically coupling the at least one electronic circuitry component with i) the portion of the plurality of electrodes and/or ii) the portion of the plurality of flexible conductive traces comprises mounting the at least one circuit circuitry component to the flexible body. 
 
     
     
       14. The system of  claim 13 , wherein the at least one circuit board component comprises one or more flex circuits, one or more rigidized flex circuits, and/or one or more rigid-flex circuits. 
     
     
       15. The system of  claim 13 , wherein the at least one circuit board component comprises one or more three-dimensionally formed circuit board components comprising at least one of i) one or more bent portions or ii) one or more curved portions. 
     
     
       16. The system of  claim 1 , wherein the flexible body comprises:
 a first section configured for aligning substantially in front of the auricle; and 
 a second section configured for aligning substantially against a back of the auricle. 
 
     
     
       17. The system of  claim 1 , wherein the flexible body comprises:
 an auricle-mounting portion to be worn at least partially around the auricle of the wearer; 
 an on-ear mounting portion configured to be maintained against at least one of a concha or a cavum of an ear of the wearer; and 
 a flexible connector connecting the auricle-mounting portion to the on-ear mounting portion; 
 wherein the on-ear mounting portion comprises at least one electrode of the plurality of electrodes. 
 
     
     
       18. The system of  claim 1 , wherein the flexible body of the wearable auricular stimulator comprises at least one opening and/or at least one thinned region of material for enabling operation of a mechanical input control component of the one or more electronic circuitry components by the wearer. 
     
     
       19. The system of  claim 1 , wherein the flexible body comprises:
 a first flexible body portion comprising
 a skin-facing external side adapted to contact a portion of the skin surrounding the auricle of the wearer, and 
 an internal side opposite the skin-facing external side; and 
 
 a second flexible body portion configured to mate with the first flexible body portion, thereby substantially encapsulating the three-dimensional circuitry layout and the one or more electronic circuitry components. 
 
     
     
       20. The system of  claim 19 , wherein the second flexible body portion comprises one or more openings and/or one or more thinned regions of material for enabling electrical communication between each electrode of one or more electrodes of the plurality of electrodes and the skin of the wearer.